Breakthrough Clinical Data for LBL-024 in First-Line Treatment of Advanced EP-NEC Unveiled at 2025 ASCO Oral Session

NANJING, China, May 31, 2025 /PRNewswire/ -- Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs") today announced the presentation of groundbreaking clinical data from a multicenter phase Ib/II clinical trial evaluating LBL-024, an anti-PD-L1/4-1BB bispecific antibody, in combination with etoposide plus platinum-based chemotherapy for treatment-naive patients with advanced extrapulmonary neuroendocrine carcinoma (EP-NEC). The results were featured in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

ASCO is recognized as the world's most prestigious oncology conference, serving as a global stage for unveiling transformative scientific and clinical advancements. The Oral Sessions are highly competitive, served for studies demonstrating significant clinical relevance or scientific innovation. In 2025, ASCO received a record-breaking 7,775 abstract submissions, with 32 Chinese-led studies selected for oral presentation - among them, the LBL-024 trial (NCT06157827).

The study, led by Professor Shen Lin of Peking University Cancer Hospital and conducted across multiple clinical centers, evaluates the efficacy and safety of LBL-024 combined with etoposide plus platinum-based chemotherapy as a first-line treatment for advanced EP-NEC.

Robust Anti-Tumor Activity Observed with LBL-024 Plus Chemotherapy

• In 52 efficacy-evaluable patients, the overall response rate (ORR) across all dose levels was 75.0% and the disease control rate (DCR) was 92.3%, significantly outperforming historical ORR data (30%-55%) with chemotherapy alone.
• The 15 mg/kg in dose optimization demonstrated the strongest anti-tumor activity, achieving an ORR of 83.3% and a DCR of 100%.
• 57.7% (30/52) of the patients experienced >50% tumor shrinkage.
• As of April 15th, 2025, with a median follow-up of 8.2 months, progression-free survival (PFS) data remains immature, but trends indicate promising durability across all the dose groups.
• In the phase Ib dose escalation stage, no dose-limiting toxicities (DLTs) were observed. Most treatment-emergent adverse events (TEAEs) were Grade 1–2 and manageable, primarily associated with chemotherapy, including hematologic toxicity and nausea. No unexpected safety signals were identified. 

Leadership Perspectives

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated:" We are thrilled to share these exciting clinical data, which strongly support the advancement of LBL-024 into a pivotal phase III trial as a first-line treatment for EP-NEC. Our strategy prioritizes efficient development through single-arm registrational trial in underserved indications, while also maximizing value through broad indication expansion. LBL-024 received regulatory clearance in April 2024 to initiate a single-arm pivotal trial in China, marking the first 4-1BB targeted agent globally to reach this stage. With its expanded use now demonstrated in first-line settings and active studies in cancers such as SCLC and NSCLC, LBL-024 is poised to offer promising transformative therapeutic options for more cancer patients worldwide."

Dr. Xiaoqiang Kang, Founder, Chairman and CEO of Leads Biolabs, added, "It is deeply encouraging to see LBL-024 featured consecutively in ASCO oral presentations. From target selection to molecular design, our R&D approach has focused on differentiated innovation to address pressing clinical challenges. The success of LBL-024 reflects our commitment to pioneering innovation at the source—breaking free from homogeneity to deliver genuinely impactful therapies. We remain dedicated to addressing unmet needs, advancing breakthrough therapeutics, and improving outcomes for patients across the globe."

About LBL-024

LBL-024 is a potential first-in-class bispecific antibody simultaneously targeting PD-L1 and the co-stimulatory receptor 4-1BB. It is the first 4-1BB-targeting bispecific antibody globally to reach the single arm pivotal trial stage as a monotherapy and holds promise to become the first approved treatment specifically for extrapulmonary neuroendocrine carcinoma (EP-NEC), a malignancy with significant unmet medical need.

Developed using Leads Biolabs' proprietary X-Body™ bispecific platform, LBL-024 features a 2:2 format with two binding domains each for PD-L1 and 4-1BB, and an optimized affinity ratio. This design allows LBL-024 to both reverse PD-L1–mediated immune suppression and selectively enhance T cell activation, resulting in potent, synergistic anti-tumor effects.

In Phase I/II clinical trials in China, LBL-024 has demonstrated promising efficacy and a favorable safety profile in patients with advanced EP-NEC, both as monotherapy and in combination with chemotherapy. The lack of a standard of care in EP-NEC supports the pursuit of accelerated approval through a single-arm pivotal study.

In recognition of its clinical potential, LBL-024 received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) in China (October 2024), and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for neuroendocrine carcinoma (November 2024).

Beyond NEC, LBL-024 has shown encouraging early activity in other tumor types, including small cell lung cancer (SCLC), ovarian cancer (OC), biliary tract cancer (BTC), and with strong potential for expansion into broader indications such as non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), and gastric cancer (GC).

About Leads Biolabs

Founded in 2012, Leads Biolabs is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of innovative therapies to address underserved medical needs in oncology, autoimmune, and other severe diseases both in China and globally.

We are a front-runner in next-generation immuno-oncology treatments with a differentiated pipeline of 12 innovative drug candidates, including six clinical-stage drug candidates, of which four lead products are among the top-tier clinically advanced candidates globally.

We adopt a science-driven R&D approach and have successfully established comprehensive R&D capabilities spanning antibody discovery and engineering, in vivo and in vitro efficacy evaluation, as well as druggability assessment. We have also developed multiple proprietary technology platforms, including LeadsBody^TM platform (a CD3 T-cell engager platform), X-body^TM platform (a 4-1BB engager platform), which serve as the cornerstone for our continued innovation and have been validated by the clinical outcomes of our bispecific antibody portfolios.

We have established integrated capabilities across early discovery, translational medicine, clinical development, CMC and business development. The innovative nature and competitive strengths of our drug candidates, coupled with our global perspectives, proactive strategy, and efficient clinical validation, have made us an attractive partner for leading industry players and venture capitals. For more information, please visit https://en.leadsbiolabs.com/

SOURCE Leads Biolabs